Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

This study is currently recruiting participants.
Verified September 2012 by Philadelphia Veterans Affairs Medical Center
Sponsor:
Information provided by (Responsible Party):
Judith Long, MD, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01651117
First received: July 24, 2012
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Behavioral: Peer Mentoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT)

Resource links provided by NLM:


Further study details as provided by Philadelphia Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Measured by change in HbA1c


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
    Diabetes Distress Scale

  • Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    As measured by the Patient Health Questionnaire-2

  • Direct LDL blood levels [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: September 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Enrolled in two different time frames. No interventions will be provided to this arm. They will complete all planned surveys. Interviews, and blood draws (baseline, 6 months, and 12 months).
Experimental: Peer Mentoring
Participants in this arm will be mentored for 6 months by a veterans who was once in poor control but is now in good control. They will then become a mentor for 6 months.
Behavioral: Peer Mentoring

Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control.

Arm 3: Will receive peer mentoring from former mentees.

Experimental: Peer Mentoring FFM (from former mentee)
Participants in this arm will be mentored by the former mentee for 6 months and will be followed for an additional 6 most after the completion of the active intervention.
Behavioral: Peer Mentoring

Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control.

Arm 3: Will receive peer mentoring from former mentees.


Detailed Description:

The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) determine the cost-effectiveness of peer mentoring as implemented in this study. Secondary objectives include: (1) assess the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health; and (2) assess the effects of the program on other important health outcomes for diabetics including blood pressure, low density lipoprotein (LDL) levels, diabetes quality of life, and depression.

This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, direct LDL, diabetes quality of life and depression. We will also perform a cost-effectiveness analysis of the different interventions compared to the control arm. We will take the perspective of the payer.

The trial has 3 arms: 1. usual care; 2. peer mentoring where mentors are veterans who were once in poor control but are now in good control; and 3. peer mentoring where the mentoring comes from former mentees. Qualitative interviews with participants will provide an additional layer of insight. Determining how best to create sustainable peer mentoring models will create for the VA a new powerful tool with the potential for improving chronic disease outcomes and reducing disparities, and it will demonstrate VA leadership in creating models exportable to other settings.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants must have a diagnosis of Type 2 diabetics.
  • Diabetes began after age 30
  • Mentees: Have an HbA1c > 8% on 2 different occasions in the course of 24 months, with at least measure within 3 months of enrollment
  • Mentors: Have an HbA1c of > 8% in the past 3 years and an HbA1c < (or equal to) 7.5% within 3 months of enrollment

Exclusion Criteria:

  • Does not speak English
  • Unable to understand consents
  • Severe speech impediment
  • over the age of 75
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651117

Contacts
Contact: Kirsten M Rogers, BA 215-823-5800 ext 7929 rogerski@sas.upenn.edu
Contact: Jennifer Gutierrez, MS 215-823-5800 ext 7417 jennifer.gutierrez@va.gov

Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kirsten M Rogers, BA     215-823-5800 ext 7929     rogerski@sas.upenn.edu    
Contact: Jennifer Gutierrez, MS     215-823-5800 ext 7417     jennifer.gutierrez@va.gov    
Principal Investigator: Judith A Long, MD            
Sponsors and Collaborators
Philadelphia Veterans Affairs Medical Center
Investigators
Principal Investigator: Judith A Long, MD Philadelphia Veterans Affairs Medical Center
  More Information

Publications:
Responsible Party: Judith Long, MD, Principal Investigator, Philadelphia Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01651117     History of Changes
Other Study ID Numbers: 01373
Study First Received: July 24, 2012
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Philadelphia Veterans Affairs Medical Center:
Diabetes Mellitus
Mentors
Glucose control
Hemoglobin A, Glycosylated
Randomized Controlled Trial
Veterans

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013